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This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Participants will receive the device on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE PV1 | Device | Implantation of GORE PV1 Device for procedure to replace the pulmonary valve and reconstruct the right ventricular outflow tract (RVOT). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Valve-related mortality and device-related re-intervention | The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| MRI change in right ventricular end diastolic volume index | Six month change from baseline in right ventricular end diastolic volume index as measured from Magnetic Resonance Imaging | 6 months |
| MRI change in right ventricular end systolic volume index at 6 months |
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Inclusion Criteria:
Note: Additional Inclusion Criteria may apply
Exclusion Criteria:
Note: Additional Exclusion Criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Pedro del Nido, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurie Children's Hospital | Chicago | Illinois | 60611 | United States | ||
| Boston Children's Hospital |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D013771 | Tetralogy of Fallot |
| D011665 | Pulmonary Valve Insufficiency |
| D011666 | Pulmonary Valve Stenosis |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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Six month change from baseline in right ventricular end systolic volume index as measured from Magnetic Resonance Imaging |
| 6 months |
| MRI change in left ventricular diastolic volume index at 6 months | Six month change from baseline in left ventricular diastolic volume index as measured from Magnetic Resonance Imaging | 6 months |
| MRI change in right ventricular ejection fraction at 6 months | Six month change from baseline in right ventricular ejection fraction index as measured from Magnetic Resonance Imaging | 6 months |
| Echo change in right ventricular diastolic area at 12 months | Twelve month change from baseline in right ventricular diastolic area as measured from echocardiography | 12 months |
| Echo change in right ventricular systolic area at 12 months | Twelve month change from baseline in right ventricular systolic area as measured from echocardiography | 12 months |
| Echo change in left ventricular end diastolic volume index at 12 months | Twelve month change from baseline in left ventricular end diastolic volume index as measured from echocardiography | 12 months |
| Echo change in right ventricular fractional area change at 12 months | Twelve month change from baseline in right ventricular fractional area change as measured from echocardiography | 12 months |
| Six month mean pressure gradient <= 40 mmHG | Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 6 months | 6 months |
| Twelve month mean pressure gradient <= 40 mmHG | Number of subjects with mean pressure gradient across conduit (RV to PA) less than or equal to 40 mmHg at 12 months | 12 months |
| Six month pulmonary regurgitation < moderate | Number of subjects with pulmonary regurgitation less than moderate at 6 months | 6 months |
| Twelve month pulmonary regurgitation < moderate | Number of subjects with pulmonary regurgitation less than moderate at 12 months | 12 months |
| Device-related re-intervention at 1, 3, 6, 12, 24, 36, 48, and 60 months | Kaplan-Meier estimates of device-related re-intervention summarized at 1, 3, 6, 12 months, and annually through 5 years | 1, 3, 6, 12, 24, 36, 48, and 60 months |
| All-cause mortality at 1, 3, 6, 12, 24, 36, 48, and 60 months | Kaplan-Meier estimates of all-cause mortality summarized at 1, 3, 6, 12 months, and annually through 5 years | 1, 3, 6, 12, 24, 36, 48, and 60 months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |